1 ml of oxytocin solution contains 5 IU.

Chlorobutanol, acetic acid solution, water, as excipients.

Release form

Solution for injection in ampoules of 5 IU per 1 ml.

Pharmacological action

Stimulating labor activity .

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

What is Oxytocin? Wikipedia gives the following definition: oxytocin is a hormone hypothalamus . Here the hormone is produced and travels along the axons of neurons of the hypothalamic pituitary tract to the posterior lobe pituitary gland , which serves as a reservoir.

The hormone oxytocin is a protein in nature. It has the ability to stimulate contractions of the uterine muscles at the end of pregnancy and the entire period of labor until delivery. In general, it regulates behavioral responses associated with pregnancy and childbirth.

Currently obtained synthetically. Synthetic, unlike natural, does not contain admixtures of other hormones, therefore it has a more selective effect on the myometrium. Since the drug is free of proteins, it can be used intravenously without fear of anaphylactic effects. The mechanism of action is related to the effect on cells myometrium : membrane permeability for potassium ions increases and excitability increases. The frequency and duration of uterine contractions increases. Stimulates milk secretion, enhancing hormone production (lactogenic hormone) and increasing the contraction of cells of the lactating mammary gland. Has an unexpressed antidiuretic effect. Has virtually no effect on blood pressure.

Pharmacokinetics

After intravenous administration, the effect appears immediately and gradually decreases (up to 1 hour); with intramuscular administration, the effect appears after 3–5 minutes and lasts from 30 minutes to 3 hours. The effect is individual, which is explained by the density of oxytocin receptors in the muscle cells of the uterus. It is quickly absorbed into the bloodstream through the nasal mucosa. Protein binding is about 30%. T ½ 1-6 minutes, this period is shortened in late pregnancy and during breastfeeding. Metabolized in the liver and kidneys. Excreted by the kidneys.

Indications for use

• excitation And stimulation labor activity ;
• labor induction for medical reasons ( Rhesus conflict , , post-term pregnancy , intrauterine fetal death, premature rupture of water);
• prevention of bleeding after or after curettage;
• incomplete abortion ;
• acceleration of uterine contractions in the early postpartum period;
• increased contraction of the uterus during (injection is performed after removal of placenta);
• premenstrual syndrome, which is accompanied by edema and weight gain;
• hypolactation after childbirth.

Contraindications

• increased sensitivity;
• high blood pressure ;
• severe disorders of the cardiovascular system;
• impending uterine rupture ;
• discrepancy between the sizes of the fetus and the pelvis of the woman in labor;
• availability postoperative scars on the uterus;
• transverse and oblique position of the fetus;
• narrow pelvis;
• suspicion of placental abruption ahead of time;
• placenta previa;
• intrauterine fetal hypoxia ;
• hypertensive contractions of the uterus;
• heavy preeclamptic toxemia .

Side effects

• nausea, vomiting;
• allergic reactions;
• and bradycardia;
• increased blood pressure;
• urinary retention;
• excessive labor, which leads to premature placental abruption and the risk of uterine rupture;
• subarachnoid bleeding e;
• decline fibrinogen in the fetus;
• neonatal jaundice .

Oxytocin injections, instructions for use (Method and dosage)

The drug in injection form is administered intravenously or intramuscularly.

Instructions for use of Oxytocin

During childbirth, 0.5-2.0 IU of oxytocin is used intramuscularly to induce labor. Injections can be repeated every 30-60 minutes. If there is a need for drip administration of the drug, then 1 ml (5 IU) is diluted in 500 ml of 5% glucose solution. First, inject at a rate of 5-8 drops per minute, then, depending on labor activity, increase the speed to a maximum of 40 drops per minute.

With a purpose prevention of bleeding after childbirth on the first day, 5-8 IU is prescribed intramuscularly three times a day for 3 days. During a caesarean section, injections of 3-5 IU are given into the wall of the uterus (after the fetus is removed). An overdose of oxytocin during childbirth can cause jaundice of newborns , conditioned drug hemolysis .

Instructions for use for animals

Exists veterinary drug, which contains 5 or 10 units in 1 ml oxytocin . In veterinary medicine, it is used for prolonged labor in animals, retained placenta, postpartum uterine bleeding, and for the treatment endometritis , agalactia (lack of milk) and mastitis .

One-time use: dogs administered - 5-10 units depending on weight, cats - 2-3 units. For a quick effect, intravenous administration of glucose solution is practiced, in which case the dose is reduced by 30%. Repeated administration is possible, but the response to the drug decreases with each administration.

Oxytocin for abortion

Oxytocin has abortifacient - causes contractions and provokes miscarriage. Its use for this purpose is permissible for periods of up to 4-5 weeks, but more often gynecologists use And .

Oxytocin is also used during pregnancy from 14 weeks during induced abortion for medical reasons (frozen pregnancy, developmental defects in the child). The drug is injected into the cervical area after administration Mifepristone And Misoprostol , if the miscarriage was not complete or with an incomplete spontaneous miscarriage, but intravenous infusions are more often performed. However, in the second trimester the drug often causes hypertonicity of the uterus . Even with adequate use, hypertensive uterine contractions can occur with hypersensitivity her to oxytocin.

Medical abortion is carried out only in a medical institution under the supervision of a doctor, monitoring the contractile function of the uterus and general condition women. The doctor must make sure that the fertilized egg has left the uterine cavity. In addition, the procedure is dangerous due to bleeding.

The dosage of Oxytocin for termination of pregnancy is determined by the doctor, since the frequency of uterine contractions and their duration depend on it. Women who have , abnormalities of the uterus , scars on the neck termination of pregnancy Oxytocin contraindicated.

Overdose

It manifests itself as symptoms of uterine hyperstimulation, which leads to tetanic contractions, rupture, and bleeding. The fetus has bradycardia , hypoxia And asphyxia , birth injuries.

If symptoms of overdose appear, immediately stop administering the drug, reduce fluid intake, and prescribe diuretics, hypertonic saline solutions, and barbiturates.

Interaction

The drug potentiates the vasoconstrictor effect of sympathomimetics. Use with caution with And , as the risk increases arterial hypotension .

Inhalation agents For weaken its effect on the uterus. Prostaglandins enhance its stimulating effect. Use with MAO inhibitors poses a risk arterial hypertension .

Terms of sale

Dispensed by prescription.

Storage conditions

At a temperature of 4-15° C.

Best before date

Analogs

Oxytocin-Vial , Oxytocin-Ferein , Oxytocin-Grindeks , Oxytocin-Richter , Oxytocin-MEZ , Pitocin , Syntocinon .

Vasopressin and Oxytocin

This is also a hormone synthesized by neurons of the hypothalamic nuclei, like oxytocin. They have much in common in their structure, but have different physiological effects. Vasopressin, or antidiuretic hormone , renders antidiuretic And vasoconstrictor effects . The main function is to increase the reabsorption of water in the kidneys during a decrease in blood pressure or circulating blood volume.

Reviews about Oxytocin

Oxytocin - what is it? Oxytocin is the “love hormone”; it is not for nothing that it is called that, since increased levels are detected in women and men during the period of falling in love. It helps to strengthen emotional and sexual affection and tenderness between representatives of different sexes. This has been repeatedly proven in studies: injection of a nasal spray leads to increased libido and improved sex life. In addition, it is called the “elixir of trust.” Persons with increased level of this hormone, they are inclined to trust other people, become more kind and open.

Particularly high levels of the hormone are produced in women at the time of childbirth - this condition can be called an “oxytocin explosion.” Thus, when feeding, oxytocin is produced, since the sucking reflex contributes to its formation. This speeds up uterine contractions and reduces the risk of postpartum hemorrhage. The hormone helps strengthen the bond between mother and baby and determines the maternal instinct, increased care and tenderness towards the child. A slightly smaller “explosion” of oxytocin is observed during orgasm.

An interesting fact is that a nasal spray containing oxytocin reduces appetite and desire for food. fatty foods. The researchers found that the volunteers consumed less food after using the spray. Currently, research is ongoing into the effect of oxytocin on the brain activity of autistic children. Because activation of those areas of the brain that are depressed in these children was detected.

Another study noted similar effects of alcohol and oxytocin on human behavior. acting on different receptors, they cause similar changes in GABA in limbic structures, which are responsible for the perception of stress and anxiety. This hormone reduces feelings of anxiety and fear, and on the other hand, provokes rash actions and causes aggressive and risky behavior.

What foods contain oxytocin? Can it be replenished by eating? The hormone oxytocin is not contained in food, so it does not enter the body from the outside. It has only been established that eating dates stimulates its synthesis during pregnancy and childbirth. Taking dates, which contain more than 10 elements and a large amount of fructose, is recommended a few days before giving birth. Stimulate the release of this hormone by stroking and hugging, the pleasant voice of a partner, massage of the feet and earlobes.

For many years, the drug has been the most effective for stimulating weak labor, treating uterine bleeding, medicinal interruption pregnancy, therefore it is often used in obstetric and gynecological practice. Analyzing the reviews, we can conclude that the drug was indeed prescribed to many during and after childbirth. Some women experienced a sharp increase in contractions and, accordingly, pain, and some “did not respond” to the administration of the drug - this depends on individual sensitivity.

Now that we have figured out what it is, learned about the indications, contraindications and side effects of it as a drug, we must say that experimenting at home and trying to disrupt early pregnancy Oxytocin not safe. In essence, this is a criminal abortion, and the consequences of using the drug for this purpose are unpredictable: loss reproductive function, bleeding of varying degrees and even death. In addition, it is impossible to purchase this drug at a pharmacy, since you need a prescription in Latin, written by a doctor. To preserve your health, use legal methods of terminating a pregnancy!

This drug is used for animals, and in this case you need to know what dosages are used in veterinary medicine. Questions about this are often asked on forums. Eat general rules use of the drug. It is used only after the birth of the first puppy or kitten, when the cervix is ​​dilated, otherwise it can cause uterine rupture. If it does not work, you cannot take a second dose. It is contraindicated to speed up labor by giving injections after the birth of each puppy. It is not recommended to give injections if the dog is pushing to no avail and you suspect that the puppy is “stuck”. During childbirth, 0.3-0.4 ml is injected intramuscularly into a cat; if there is weakness in labor and protracted labor, there is doubt that not all kittens were born. If the drug was not used during childbirth, it is administered after the end of labor in a dose of 0.3 ml. The dosage for dogs is 1-2 ml depending on weight.

Oxytocin price, where to buy

You can buy the drug in Moscow at any pharmacy. The price of ampoules of Oxytocin 5 IU 1 ml No. 5 ranges from 54 rubles. up to 65 rub. Buy a spray as well Oxytocin in tablets (it is represented by the drug Desaminooxytocin , Demoxytocin , Sandopart ) is currently not possible.

Catad_pgroup Products for obstetric practice

Oxytocin - Gedeon Richter - official* instructions for use

INSTRUCTIONS
By medical use drug

Registration number:

P N013027/01

Trade name of the drug: OXYTOCIN

International generic name(INN): oxytocin

Chemical name: oxytocin

Dosage form:

solution for intramuscular and intravenous administration.

Compound:

The active ingredient is oxytocin 5 IU in each ampoule. Excipients – glacial acetic acid 2.50 mg; chlorobutanol hemihydrate 3.00 mg; ethanol (96%) 40.00 mg; water for injection until 1.00 ml of solution is obtained in each ampoule.

Description:
Colorless, transparent solution, practically free from mechanical inclusions.

Pharmacological properties

Pharmacotherapeutic group:

Labor stimulant drug oxytocin.
ATX code:Н01В В02
Pharmacodynamics: A synthetic hormonal agent with pharmacological and clinical properties similar to endogenous oxytocin of the posterior pituitary gland.
Interacts with oxytocin-specific receptors of the uterine myometrium, belonging to the G-protein superfamily. The number of receptors and the response to the action of oxytocin increase as pregnancy progresses and reach a maximum towards the end of it. Stimulates labor activity of the uterus by increasing the permeability of cell membranes to Ca + and increasing the intracellular concentration of the ion, subsequently reducing the resting potential of the membrane and increasing its excitability. Causes contractions similar to normal spontaneous labor, temporarily reducing the blood supply to the uterus. With an increase in the amplitude and duration of muscle contractions, the cervix of the uterus expands and smoothes. In appropriate quantities, it can enhance the contractility of the uterus from moderate in strength and frequency, characteristic of spontaneous motor activity, to the level of prolonged tetanic contractions.
Causes contraction of myoepithelial cells adjacent to the alveoli mammary gland, improving the release of breast milk.
By acting on vascular smooth muscle, it causes vasodilation and increases blood flow in the kidneys, coronaries and blood vessels brain. Usually, blood pressure remains unchanged, but with intravenous administration of large doses or a concentrated solution of oxytocin, blood pressure may temporarily decrease with the development of reflex tachycardia and a reflex increase in cardiac output. Following the initial decrease in blood pressure, there is a prolonged, albeit small, increase.
Unlike vasopressin, oxytocin has minimal antidiuretic effects, however, overhydration is possible when oxytocin is administered with large amounts of electrolyte-free fluids and/or when they are administered too quickly. Does not cause muscle contraction bladder and intestines.
Pharmacokinetics: When administered intravenously, the effect of oxytocin on the uterus appears almost instantly and lasts for 1 hour. When administered intramuscularly, the myotonic effect occurs in the first 3-7 minutes and lasts for 2-3 hours.
Like vasopressin, oxytocin is distributed throughout the extracellular space. Small amounts of oxytocin appear to enter the fetal circulation. The half-life is 1-6 minutes, it is shorter in late pregnancy and lactation. Most of the drug is rapidly metabolized in the liver and kidneys. During the process of enzymatic hydrolysis, it is inactivated, primarily under the action of tissue oxytokinase (oxytokinase is also found in the placenta and plasma). Only a small amount of oxytocin is excreted unchanged in the urine.

Indications
Oxytocin is intended to induce labor and stimulate labor.
Labor induction in late or close stages of pregnancy, if early delivery is necessary due to gestosis, rhesus conflict, early or premature rupture of fetal membranes and discharge of amniotic fluid, post-term pregnancy (more than 42 weeks), intrauterine growth retardation, intrauterine fetal death.
Stimulation of labor: with primary or secondary weakness of labor in the first or second stages of labor.
Prevention and treatment of hypotonic bleeding after childbirth and abortion, during cesarean section (after the birth of a child and separation of the placenta), to accelerate postpartum involution.
Others: as an additional therapy for incomplete or incomplete (inevitable) abortion.

Contraindications
Increased sensitivity to oxytocin; the presence of contraindications for vaginal birth (for example, presentation or prolapse of the umbilical cord, complete or partial (vasa previa) placenta previa; narrow pelvis (discrepancy between the sizes of the fetal head and the pelvis of the woman in labor); transverse and oblique position of the fetus, preventing spontaneous delivery; emergency, requiring surgical intervention situations caused by the condition of the mother or fetus; states of fetal distress long before the terminal stages of pregnancy; long-term use with inertia of the uterus; severe gestosis (high blood pressure, impaired renal function); hypertonicity of the uterus (not arising during childbirth); uterine sepsis, heart disease, arterial hypertension, impaired renal function, facial presentation of the fetus, excessive distension of the uterus, fetal compression.
Except in special circumstances, the drug is also contraindicated in following situations: premature birth; major surgery on the uterus or cervix (including C-section) in the anamnesis; hypertonicity of the uterus; multipod pregnancy; invasive stage of cervical carcinoma.

Pregnancy and lactation
In the first trimester of pregnancy, oxytocin is used only for spontaneous or induced abortions. Numerous data on the use of oxytocin, its chemical structure And pharmacological properties indicate that if the instructions for use are followed, oxytocin does not affect the formation of fetal malformations.
Passes into breast milk in small quantities.
When using the drug to stop uterine bleeding, breastfeeding can be started only after completing the course of treatment with oxytocin.

Directions for use and doses
Intravenously or intramuscularly.
With the chain of induction and enhancement of labor, oxytocin is used exclusively intravenously, in a hospital setting, with appropriate medical supervision. Simultaneous use of the drug intravenously and intramuscularly is contraindicated. The dose is selected taking into account the individual sensitivity of the pregnant woman and the fetus.
To induce labor and stimulate labor, oxytocin is used exclusively in the form of an intravenous drip infusion. Strict control of the prescribed infusion rate is mandatory. The safe use of oxytocin during induction and enhancement of labor requires the use of an infusion pump or other similar device, as well as monitoring of the strength of uterine contractions and fetal cardiac activity. In case of excessive increase in contractile activity of the uterus, the infusion should be stopped immediately; as a result, excessive muscle activity of the uterus quickly decreases.
1) Before you start administering the drug, you should start administering a saline solution that does not contain oxytocin.
2) To prepare a standard oxytocin infusion, dissolve 1 ml (5 IU) of oxytocin in 1000 ml of non-hydrating fluid and mix thoroughly by rotating the bottle. 1 ml of infusion prepared in this way contains 5 mIU of oxytocin. For precise dosing infusion solution an infusion pump or other similar device should be used.
3) The rate of administration of the initial dose should not exceed 0.5-4 milliunits per minute (mU/min) (corresponds to 2-16 drops/min, since 1 drop of infusion contains 0.25 mU of oxytocin). Every 20-40 minutes it can be increased by 1-2 mIU/min until the desired degree of uterine contractility is achieved. Once the desired frequency of uterine contractions has been achieved, corresponding to spontaneous labor, and the uterine os is dilated to 4-6 cm, in the absence of signs of fetal distress, the infusion rate can be gradually reduced at a rate similar to its acceleration.
In late pregnancy, infusion at a higher rate requires caution; only in rare cases may a rate exceeding 8-9 mU/min be required. In case of premature birth, a higher speed may be required, which in isolated cases may exceed 20 mU/min (80 drops/min).
1) The fetal heartbeat, the tone of the uterus at rest, the frequency, duration and strength of its contractions should be monitored.
2) In case of uterine hyperactivity or fetal distress, oxytocin should be stopped immediately and oxygen therapy should be provided to the parturient. The condition of the mother and fetus should be re-monitored by a medical specialist.
Prevention and treatment of hypotonic bleeding in the postpartum period:
1) Intravenous drip infusion: dissolve 10-40 IU of oxytocin in 1000 ml of non-hydrating liquid; to prevent uterine atony, 20-40 IU/min of oxytocin is usually necessary.
2) Intramuscular administration: 5 IU/ml oxytocin after separation of the placenta.
Incomplete or failed abortion:
Add 10 IU/ml of oxytocin to 500 ml of saline solution or a mixture of 5% dextrose with saline solution. The intravenous infusion rate is 20-40 drops/min.

Side effect
For women in labor:
From the reproductive system: with large doses or hypersensitivity - uterine hypertension, spasm, tetany, uterine rupture, increased bleeding in the postpartum period as a result of oxytocin-induced thrombocytopenia, afibrinogenemia and hypoprothrombinemia, sometimes hemorrhage in the pelvic organs. With careful medical monitoring during labor, the risk of bleeding in the postpartum period is reduced.
From the cardiovascular system: at high doses – arrhythmia; ventricular extrasystole; severe hypertension (in the case of using vasopressor drugs); hypotension (when used simultaneously with the anesthetic cyclopropane); reflex tachycardia; shock; if administered too quickly: bradycardia, subarachnoid bleeding.
From the digestive system: nausea, vomiting.
From the side of water-electrolyte metabolism: severe overhydration with prolonged intravenous administration (usually at 40-50 mU/min) with large amounts of fluid (antidiuretic effect of oxytocin), occurring with convulsions and coma is possible with a 24-hour, slow infusion of oxytocin; rarely – death.
From the outside immune system: anaphylaxis and other allergic reactions, with too rapid administration bronchospasm; rarely – death
In the fetus or newborn:
As a consequence of the administration of oxytocin to the mother - within 5 minutes a low Apgar score, jaundice of newborns, with too rapid administration - a decrease in fibrinogen in the fetal blood, hemorrhage in the retina; as a result of increased contractile activity of the uterus - sinus bradycardia, tachycardia, ventricular extrasystole and other arrhythmias, residual changes in the central nervous system, fetal death as a result of asphyxia.

Overdose
Symptoms depend mainly on the degree of uterine hyperactivity, regardless of the presence of hypersensitivity to the drug. Hyperstimulation with hypertonic and tetanic contractions or with a baseline tone of ≥15-20 mm aq. Art. between two contractions leads to disordered labor, rupture of the body or cervix, vagina, bleeding in the postpartum period, uteroplacental insufficiency, fetal bradycardia, hypoxia, hypercapnia, compression, birth injuries or death. Overhydration with convulsions as a result of the antidiuretic effect of oxytocin is a serious complication and develops with prolonged administration of large doses (40-50 ml/min).
Treatment of overhydration: withdrawal of oxytocin, restriction of fluid intake, use of diuretics to force diuresis, intravenous administration of hypertonic saline solution, correcting electrolyte imbalances, controlling seizures with appropriate doses of barbiturates, and providing professional care for the comatose patient.

Drug interactions
When oxytocin is administered 3-4 hours after the use of vasoconstrictors together with caudal anesthesia, severe arterial hypertension.
During anesthesia with cyclopropane and halothane, the cardiovascular effect of oxytocin may change with the unexpected development of arterial hypotension, sinus bradycardia and atrioventricular rhythm in a woman in labor during anesthesia.

Special instructions
Before starting to use oxytocin, the expected beneficial effect of therapy should be compared with the possibility, although rare, of the development of hypertension and uterine tetany.
Until the fetal head is inserted into the pelvic inlet, oxytocin cannot be used to induce labor.
Every patient receiving intravenous oxytocin should be hospitalized under the constant supervision of experienced professionals who are familiar with the drug and recognized as skilled in recognizing complications. Immediate, if necessary, assistance from a medical specialist must be provided. During use of the drug, uterine contractions, cardiac activity of the mother and fetus, and blood pressure of the woman in labor should be constantly monitored to avoid complications. If there are signs of uterine hyperactivity, oxytocin should be discontinued immediately; As a result, uterine contractions caused by the drug usually subside soon.
When used adequately, oxytocin causes uterine contractions similar to spontaneous labor. Excessive stimulation of the uterus if the drug is used incorrectly is dangerous for both the mother and the fetus. Even with adequate use of the drug and appropriate monitoring, hypertensive uterine contractions occur with increased sensitivity of the uterus to oxytocin.
The risk of developing afibrinogenemia and increased blood loss should be taken into account.
There are cases of death of a woman in labor as a result of hypersensitivity reactions, subarachnoid hemorrhage, uterine rupture and fetal death for various reasons associated with parenteral administration of the drug for induction of labor and stimulation in the first and second stages of labor.
As a result of the antidiuretic effect of oxytocin, overhydration may develop, especially when using a constant infusion of oxytocin and ingesting liquids.
The drug can be diluted in solutions of sodium lactate, sodium chlorate and glucose. The prepared solution should be used within the first 8 hours after preparation. Compatibility studies were carried out with 500 ml infusions.
Effect of the drug on the ability to drive a car and machinery, work on which is associated with an increased risk of injury: oxytocin does not affect the ability to drive a car and machinery, work on which is associated with an increased risk of injury.

Release form
1 ml solution for injection in a glass ampoule, 5 ampoules in a cardboard box with instructions for medical use.

Best before date
3 years.
Do not use the drug after the expiration date indicated on the package.

Storage conditions
Store at a temperature of 2-15 °C, protected from light, out of the reach of children.

Conditions for dispensing from pharmacies
According to the recipe.

Manufacturer
Gedeon Richter A.O.
1103 Budapest, st. Diemrei, 19-21, Hungary Moscow Representative Office: st. Krasnaya Presnya, 1-7.

Hormones of the posterior lobe of the pituitary gland.

ATS code NO1B B02.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Oxytocin is a cyclic nonapeptide produced by chemical synthesis. This synthetic form is identical to the natural hormone, which is synthesized in the posterior lobe of the pituitary gland and enters the systemic circulation in response to sucking during breastfeeding and labor activity.

Oxytocin stimulates the smooth muscles of the uterus, more strongly towards the end of pregnancy, during childbirth and immediately after childbirth. At this time, the number of oxytocin receptors in the myometrium increases. Oxytocin receptors are G-protein coupled receptors. Activation of oxytocin receptors causes the release of calcium from intracellular stores and thus leads to myometrial contraction. Oxytocin causes rhythmic contractions in the upper segment of the uterus, similar in frequency, strength and duration to the contractions observed during labor.

Being synthetic, oxytocin does not contain vasopression, but even in its pure form, oxytocin has some weak vasopressin-like antidiuretic effects.

In vitro studies have shown that long-term exposure to oxytocin causes desensitization of oxytocin receptors, which is likely due to downregulation of oxytocin-binding sites, destabilization of oxytocin receptor mRNAs, and internalization of oxytocin receptors.

Plasma levels and onset/duration of effect

Intravenous infusion.

When oxytocin is administered by continuous intravenous infusion in doses used to induce or stimulate labor, the uterine response occurs gradually and usually reaches a stable level within 20-40 minutes. At the same time, plasma oxytocin levels are comparable to those measured during the spontaneous first stage of labor. For example, plasma oxytocin levels in 10 late pregnant women receiving 4 milliunits per minute of oxytocin by intravenous infusion were 2-5 microunits/mL. After the infusion is stopped or the infusion rate is significantly reduced, for example in the case of hyperstimulation, uterine activity decreases sharply, but may continue at a fairly low level.

Pharmacokinetics

Absorption

Plasma oxytocin levels in late pregnant women following an intravenous infusion of 4 milliunits per minute were 2-5 microunits/mL.

Distribution

Steady-state volume of distribution determined at 6 healthy person, after intravenous injection amounted to 12.2 l or 0.17 l/kg. The binding of oxytocin to plasma proteins is negligible. It crosses the placenta in both directions. Oxytocin can be detected in small quantities in breast milk.

Biotransformation/Metabolism

Oxytocinase is a glycoprotein aminopeptidase, which is produced during pregnancy, enters the plasma, and is capable of degrading oxytocin. Oxytocinase is produced in both the mother and the fetus. The liver and kidneys play an important role in the metabolism of oxytocin and its elimination from plasma. Thus, the liver, kidneys and systemic circulation contribute to the biotransformation of oxytocin.

Elimination

The half-life of oxytocin ranges from 3 to 20 minutes. Metabolites are excreted from the body in the urine; less than 1% of oxytocin is excreted unchanged in the urine. The clearance of oxytocin in the body of a pregnant woman is up to 20 ml/kg/min.

Kidney failure

Studies in patients with renal failure were not carried out. However, given the excretion of oxytocin and its reduction due to the antidiuretic properties of oxytocin, possible accumulation of oxytocin may lead to prolonged action.

Liver failure

Studies have not been conducted in patients with liver failure.

Changes in pharmacokinetics in patients with impaired liver function are unlikely, since the metabolizing enzyme oxytocinase is not only found in the liver; oxytocinase levels in the placenta increased significantly during pregnancy. Therefore, the biotransformation of oxytocin in liver dysfunction cannot lead to significant changes in the metabolic clearance of oxytocin.

Indications for use

In the prenatal period:

Induction of labor for medical reasons, such as post-term pregnancy, premature rupture of membranes, pregnancy-induced hypertension (preeclampsia);

Stimulation of labor in case of uterine hypotension;

On early stages pregnancy as adjuvant therapy for incomplete, inevitable, failed abortion.

In the postpartum period:

During a caesarean section, but after the baby has been removed;

Prevention and treatment of postpartum uterine atony and bleeding.

Contraindications

Hypersensitivity to the active or excipients.

Uterine hypertonicity, mechanical obstruction to vaginal delivery, fetal distress.

Conditions of the mother or fetus in which spontaneous birth through the birth canal is inappropriate and/or contraindicated:

Clinically narrow pelvis;

Malpresentation of the fetus:

Placenta previa or vasa previa;

Placental abruption;

Presentation or prolapse of the umbilical cord;

Overstretching or threat of uterine rupture, for example, during multiple pregnancies;

Polyhydramnios;

Uterus after multiple births;

The presence of a postoperative scar on the uterus, including after a cesarean section. Oxytocin should not be used long-term in patients with uterine resistance to oxytocin, severe preeclamptic toxemia, or severe cardiovascular disorders.

Oxytocin should not be used within 6 hours after using vaginal prostaglandins (see section "Interactions with other drugs").

Directions for use and dosage

Induction and stimulation of labor.

Oxytocin should not be administered within 6 hours of using vaginal prostaglandins.

The drug is administered by intravenous drip infusion, preferably using an infusion pump with adjustable speed. For drip infusion, it is recommended to dissolve 5 IU of Oxytocin-Biolek in 500 ml of physiological electrolyte solution (for example, sodium chloride 0.9%). For patients for whom sodium chloride infusion is contraindicated, 5% dextrose solution can be used as a diluent (see section "Precautions"). To ensure uniform mixing, the container with the solution should be turned upside down several times before use.

The initial infusion rate should be 1-4 milliunits/minute (2-8 drops/minute). The rate can be gradually increased by no more than 1 to 2 milliunits/minute at intervals of at least 20 minutes until contractile activity consistent with normal labor is achieved. In full-term pregnancy, such contractions can be achieved with an infusion rate of less than 10 milliunits/minute (20 drops/minute), with a recommended maximum rate of 20 milliunits/minute (40 drops/minute). In cases where a higher infusion rate may be required, such as intrauterine fetal death or induction of labor earlier in pregnancy when the uterus is less sensitive to oxytocin, a more concentrated solution of oxytocin, such as 10 IU per 500 ml, is recommended.

When using an infusion pump, which allows the administration of smaller volumes compared to an IV, the concentration required to obtain the required dose of oxytocin should be calculated depending on the pump specification.

During the infusion, the frequency, strength and duration of contractions of the mother's uterus and the fetal heart rate should be carefully monitored. Once a sufficient level of uterine activity has been achieved (3-4 contractions every 10 minutes), the infusion rate can be reduced. If uterine hyperstimulation and/or fetal distress occurs, the infusion should be stopped immediately.

If, after an infusion of oxytocin at a dose of 5 IU, a patient with a full-term pregnancy or at a period close to full-term cannot achieve regular labor, it is recommended to stop trying to induce labor. The attempt can be repeated the next day, again starting with an infusion rate of 1-4 milliunits/minute (see section "Contraindications").

Incomplete, inevitable, failed abortion

Intravenous infusion 5 IU (IU of oxytocin diluted in saline electrolyte solution, administered as an intravenous drip over 5 minutes, or preferably using a variable-rate infusion pump), subsequently infused at a rate of 20 to 40 milliunits/min if necessary .

Kesarevo section

Intravenous infusion 5 IU (5 IU of oxytocin diluted in saline electrolyte solution, administered by intravenous drip infusion or, preferably, using a rate-controlled infusion pump, over 5 minutes, or, preferably, using a rate-controlled infusion pump, in within 5 minutes) immediately after removing the child.

Prevention of postpartum uterine bleeding

The usual dose is 5 IU by intravenous infusion (5 IU of oxytocin diluted in saline electrolyte solution administered by intravenous drip infusion, or preferably using a rate-controlled infusion pump, over 5 minutes) after separation of the placenta. In women receiving oxytocin for induction or stimulation of labor, the infusion should be continued with increased speed during the third stage of labor and for the next few hours after its end.

Treatment afterintrapartum uterine bleeding

Intravenous infusion of 5 IU (5 IU of oxytocin diluted in saline electrolyte solution, administered by intravenous drip infusion, or preferably using a rate-controlled infusion pump, over 5 minutes), then in severe cases, infusion of a solution containing 5-IU 20 IU of oxytocin in 500 ml of electrolyte diluent, at the rate necessary to control uterine atony.

Method of administration: intravenous infusion.

Special groups

Kidney failure

Studies have not been conducted in patients with renal failure.

Liver failure

No studies have been conducted in patients with hepatic impairment.

Children

Studies on the use of the drug in the pediatric population have not been conducted.

Elderly

Studies on the use of the drug in persons aged 65 years and older have not been conducted.

Precautions

Oxytocin-Biolek should be administered exclusively by intravenous drip infusion.

Do not use the drug as an intravenous bolus as this may cause acute

short-term hypotension, accompanied by hyperemia and reflex tachycardia.

Induction of labor

Induction of labor with oxytocin should only be performed for strict medical reasons. Oxytocin is administered only in a hospital setting and under qualified medical supervision.

Cardiovasculardisorders

Oxytocin-Biolek should be used with caution in patients with a predisposition to myocardial ischemia due to a history of cardiovascular disease (for example, hypertrophic cardiomyopathy, valvular pathology and/or coronary artery disease, including coronary artery spasm), in order to avoid significant changes blood pressure and heart rate.

QT syndrome

Oxytocin-Biolek should be prescribed with caution to patients with “long QT syndrome” or symptoms associated with it, as well as to patients who are using drugs that prolong the QT interval (see section “Interaction with other drugs”).

ApplicationOxytocin-Biolekfor induction and stimulation of labor:

- Distressfetus and fetal death: administration of oxytocin in excessive doses leads to uterine hyperstimulation, which can cause fetal distress, asphyxia and death, as well as hypertonicity, tetany and uterine rupture. Therefore, it is necessary to carefully monitor the fetal heart rate, as well as the frequency, strength and duration of uterine contractions in order to adjust the dosage of the drug depending on the individual response.

Particular caution is required in the presence of a clinically narrow pelvis, secondary labor weakness, mild to moderate hypertension caused by pregnancy or heart disease, and when used in patients over the age of 35 years or with a history of cesarean section in the lower segment of the uterus.

Disseminated intravascular coagulation (DIC): In rare cases of pharmacological induction of labor, the use of uterotonic drugs, including oxytocin, increases the risk of DIC. This risk is associated with pharmacological induction in general and not with any specific drug. This risk increases, in particular, if a woman has additional factors risk of developing DIC, such as age 35 years or older, complications during pregnancy, and gestational age greater than 40 weeks. In this category of women, oxytocin or any other alternative drug should be used with caution, and the physician should be alert for DIC syndrome.

Intrauterine fetal death

In the case of intrauterine fetal death and/or the presence of meconium in the amniotic fluid, induction of labor should be avoided, as this may lead to amniotic fluid embolism.

Water intoxication

Since oxytocin has little antidiuretic activity, its long-term intravenous administration into high doses in combination with large volumes of fluid, for example, with an inevitable and failed abortion, postpartum hemorrhage, can lead to water intoxication associated with hyponatremia. The antidiuretic effect of oxytocin in the setting of intravenous hydration can lead to fluid overload and a hemodynamic form of acute pulmonary edema without hyponatremia. To avoid these rare complications, the following precautions must be observed: with long-term use of high doses of oxytocin, it is necessary to use electrolyte solutions as a solvent (not dextrose), limit the volume of fluid administered (introducing oxytocin at a higher concentration than recommended for induction and stimulation of labor), limit oral fluid intake, monitor water balance, and if there is an imbalance, determine the level of electrolytes in the blood serum.

Kidney failure

Caution should be exercised in patients with severe renal failure due to possible water retention and accumulation of oxytocin (see section "Pharmacokinetics").

Use during pregnancy and lactationfishing

Animal reproduction studies have not been conducted using oxytocin. Wide experience with the use of oxytocin, its chemical structure and pharmacological properties indicate that when the drug is used in accordance with the indications, the risk of developing abnormalities in the fetus is unlikely.

Oxytocin is found in small amounts in breast milk. However, it is unlikely to have any adverse effects on the newborn. since when it enters the digestive tract, oxytocin is quickly inactivated.

The ability to influence the reaction rate when driving vehicles orand working with other mechanisms

Oxytocin can induce uterine contractions, so when using the drug you should not control vehicles or work with machinery. Women with uterine contractions should not drive cars or operate machinery.

Interaction with other medicinal productsdstvom

Prostaglandins and their analogues

Prostaglandins and their analogues promote myometrial contraction; therefore, oxytocin can potentiate the effect of these drugs on the uterus, and vice versa (see section “Contraindications”).

Medicines that prolong the interval Q T

Oxytocin should be considered as a potentially arrhythmogenic drug, especially in patients with other risk factors for developing atrial fibrillation, for example, the use of drugs that prolong the QT interval, or a history of long QT syndrome (see section "Precautions").

Inhalational anesthetics

Inhalational anesthetics (eg, cyclopropane, halothane, sevoflurane, desflurane) have a relaxing effect on the uterus and lead to a marked decrease in its tone, thereby reducing the uterotonic effect of oxytocin. Their simultaneous use with oxytocin can lead to impairment heart rate. Vasoconstrictors/Sympathomimetics

Oxytocin can enhance the vasopressor effects of vasoconstrictors and sympathomimetics, including those contained in local anesthetics,

Caudal anesthetics

When administered during or after caudal anesthesia, oxytocin may potentiate the pressor effect of sympathomimetic vasoconstrictors.

Side effect

Given the wide variability in the sensitivity of the uterus to oxytocin, in some cases, administration of the drug in small doses may lead to uterine spasms.

Intravenous administration of excessively high doses of oxytocin for induction and stimulation of labor can cause distress, asphyxia, fetal death, as well as hypertonicity, tetany, soft tissue damage, and uterine rupture.

A rapid intravenous bolus injection of oxytocin in doses of several IU can lead to acute short-term hypertension, accompanied by hyperemia and reflex tachycardia (see section "Precautions"), prolongation of the QT interval. Rapid changes in hemodynamics can cause myocardial ischemia, especially in patients with a history of cardiovascular disease.

In rare cases, pharmacological induction of labor using uteronics, including oxytocin, increases the risk of postnatal disseminated intravascular coagulation (see Precautions).

Water intoxication

Water intoxication, associated with maternal and fetal hyponatremia, occurs with long-term use of high doses of oxytocin concomitantly with large volumes of electrolyte-free fluids (see Precautions section). Antidiuretic The effect of oxytocin during intravenous fluid administration can lead to overhydration and a hemodynamic form of acute pulmonary edema without hyponatremia (see section "Precautions").

Symptoms of water intoxication include:

Headache, lack of appetite, nausea, vomiting, abdominal pain. Lethargy, drowsiness, loss of consciousness, convulsions. Low concentration of electrolytes in the blood.

Adverse reactions(Tables 1 and 2) are ranked by frequency, starting with very common, using the following frequency assessment criteria: very common (≥1/10); often (≥ 1/100,

Adverse reactions based on post-marketing experience include spontaneous reports and cases from the literature. It is therefore not possible to reliably estimate their frequency, which is therefore classified as “unknown”. Adverse reactions are listed by organ system class (MedDRA). Within each organ system class, adverse reactions are presented in descending order of severity.

Table 1. Adverse reactions in the mother:

Organ system class	Adverse reactions
From the immune system	Rare: anaphylactic/anaphylactoid reactions associated with dyspnea, hypotension or anaphylactic/anaphylactoid shock.
From the nervous system	Common: headache Not known: dizziness
From the side of the heart	Common: tachycardia, bradycardia Uncommon: arrhythmia Unknown: myocardial ischemia, prolongation of the QTc interval on the ECG, ventricular extrasystole
From the side of blood vessels	Unknown: hypertension, hypotension, hemorrhage
Gastrointestinal disorders	Common: nausea, vomiting
	Common: rash
	Unknown: hypertonicity, uterine spasms, tetanic contractions of the uterus, uterine rupture; hemorrhages in the pelvic organs; death during childbirth; postpartum hemorrhage
Metabolic and nutritional disorders	Unknown: water intoxication, maternal hyponatremia
From the respiratory system, chest and mediastinum	Unknown: acute pulmonary edema
General disorders and disorders at the injection site	Unknown: hyperemia; reactions at the injection site, including hyperemia, itching.
From the blood and lymphatic system	Not known: DIC, factor I deficiency, hypoprothrombinemia, thrombocytopenia
From the skin and subcutaneous tissues	Unknown: angioedema

Table 2. Adverse reactions in the fetus/newborn

Organ system class	Adverse reactions
Pregnancy, puerperium and perinatal conditions	Not known: fetal distress syndrome, asphyxia, fetal death, residual central nervous system lesions
Metabolism and nutrition	Unknown: neonatal hyponatremia
From the side of the heart	Unknown: sinus bradycardia, tachycardia, ventricular premature beats, arrhythmias
From the organs of vision	Unknown: retinal hemorrhage in newborns
Research	Unknown: Low Apgar score measured 5 minutes after birth

Overdose

Lethal dose not installed. Oxytocin is inactivated by proteolytic enzymes of the digestive tract. Therefore, it is not absorbed from the intestine and is likely to have no toxic effects when taken orally.

Symptoms and consequences of overdose are listed in the “Precautions” and “Side Effects” sections.

When using oxytocin preparations, uterine hyperstimulation, placental abruption, and amniotic fluid embolism have been reported.

Treatment: if signs of overdose occur, the oxytocin infusion should be stopped immediately and the woman in labor should be given oxygen. In case of water intoxication, it is necessary to limit the flow of fluid into the body, stimulate diuresis, correct electrolyte imbalance and stop convulsions that sometimes occur. In cases of coma, free breathing must be maintained using routine techniques used in the care of unconscious patients.

Package

1 ml in glass ampoules. 10 ampoules along with instructions for medical use and a scarifier approved for medical use are packaged in a pack. When packaging ampoules with a colored break ring or break point, the inclusion of a scarifier is excluded.

Vacation conditions

According to the recipe.

Aboutmanufacturer

PJSC PHARMSTANDARD-BIOLEK.

Address. 61070, Ukraine, Kharkov, Pomerki.

Name:

Oxytocin

Pharmacological
action:

Has a stimulating effect on the smooth muscles of the uterus, increases the contractile activity and tone of the myometrium (the muscular layer of the uterus), promotes the contraction of myoepithelial cells (special secretory cells) surrounding the alveoli (structural and functional formations) of the mammary glands (which facilitates the movement of milk into the large ducts and milk sinuses), has weak vasopressin-like antidiuretic properties (increases the reabsorption of water by the kidneys, i.e. reduces urine output).
With rapid jet injection has a relaxing effect on vascular smooth muscles, which leads to temporary arterial hypotension (low blood pressure) and reflex tachycardia (rapid pulse).

Pharmacokinetics. When administered intravenously, the effect of oxytocin on the uterus appears almost instantly and lasts for 1 hour. When administered, the myotonic effect occurs in the first 3–7 minutes and continues for 2–3 hours.
Like vasopressin, oxytocin is distributed throughout the extracellular space. A small amount of oxytocin is likely to enter the fetal bloodstream.
T1/2 of oxytocin is 1–6 minutes, it is shorter in late pregnancy and lactation. Most of the drug is metabolized in the liver and kidneys. During enzymatic hydrolysis, oxytocin is inactivated, mainly under the action of tissue oxytokinase (oxytokinase is also found in the placenta and blood plasma). Only a small amount of oxytocin is excreted unchanged in the urine.

Indications for
application:

Oxytocin is applied for induction and stimulation of uterine contractility.

Indications for use during the prenatal period
Induction of labor: Induction of labor with oxytocin is indicated in the last or close stages of pregnancy in the presence of hypertension (for example, preeclampsia, eclampsia or in the presence of cardiovascular and kidney disease), erythroblastosis fetalis, maternal or gestational diabetes mellitus, antepartum hemorrhage or the need for early delivery, premature rupture of the membranes, in which spontaneous contractile activity of the uterus does not occur. Planned induction of uterine contractility with oxytocin may be indicated in post-term pregnancy (more than 42 weeks). Induction of uterine contractility may also be indicated in cases of intrauterine fetal death and intrauterine growth retardation.
Increased contractility of the uterus: In the first or second stage of labor, it can be used intravenously as an infusion to intensify contractions during prolonged labor, in the absence or sluggishness of uterine contractions.

Indications in the postpartum period
For uterine hypotension, to stop postpartum hemorrhage.
Other indications for use: As adjuvant therapy for incomplete or failed abortion.
Diagnostic use: To determine the embryo-placental respiratory capacity of the fetus (stress test with oxytocin).

Directions for use:

The dose is determined taking into account individual sensitivity pregnant woman and fetus.
To induce or stimulate labor, oxytocin is used exclusively in the form of an intravenous drip infusion. Compliance with the suggested infusion rate is mandatory. Safe use of oxytocin requires the use of an infusion pump or other similar device, as well as monitoring of uterine contractions and fetal cardiac activity. In case of excessive increase in contractile activity of the uterus, the infusion should be stopped immediately, as a result of which the excessive muscular activity of the uterus quickly decreases.
Oxytocin infusion should not be administered within the first 6 hours after the use of vaginal prostaglandins.
1. Before you start administering the drug, you should start administering physiological solution, which does not contain oxytocin.
2. For cooking standard solution for infusion, the contents of 1 ampoule - 1 ml (5 IU) of oxytocin, dissolved under sterile conditions in 1000 ml of solvent (0.9% sodium solution chloride, 5% glucose solution) and mix thoroughly, rotating the container. 1 ml of solution prepared in this way contains 5 mIU of oxytocin. For accurate dosing of the infusion solution, an infusion pump or other similar device should be used.
3. The rate of administration of the initial dose should not exceed 0.5–4 mIU/min. Every 20–40 minutes it can be increased by 1–2 mIU/min until the desired degree of uterine contractility is achieved. Once the desired frequency of uterine contractions is achieved, consistent with normal labor, in the absence of signs of fetal distress and when the uterine os is 4–6 cm dilated, the infusion rate can be gradually reduced at a rate similar to its acceleration. In late pregnancy, high-rate infusions require caution, and only in rare cases may a rate of up to 8–9 mIU/min be required. In the case of preterm labor, accelerated administration of oxytocin may be necessary; rarely, the rate may exceed 20 mIU/min.
If a woman in the last or close stages of pregnancy has not achieved adequate contractile activity of the uterus after infusion of a total amount of 5 IU of oxytocin, then it is recommended to stop trying to induce labor. Induction of labor can be resumed the next day, starting with a dose of 0.5–4 mIU/min.
4. The fetal heartbeat, the tone of the uterus at rest, the frequency, duration and strength of its contractions should be monitored.
5. If uterine hyperactivity or fetal distress occurs, oxytocin should be discontinued immediately. The woman in labor should be provided with oxygen therapy. The condition of the woman in labor and the fetus must be under the supervision of a doctor.
Control of uterine bleeding during the postpartum period:
a) IV infusion (drip method): dissolve 10–40 IU of oxytocin in 1000 ml of solvent (0.9% sodium chloride solution, 5% glucose solution), 20–40 mIU is usually needed to prevent uterine atony /min oxytocin;
b) intramuscular injection of 1 ml (5 IU) of oxytocin after separation of the placenta.
Adjuvant therapy for incomplete or failed abortion
IV infusion of 10 IU of oxytocin in 500 ml of 0.9% sodium chloride solution or a mixture of 5% dextrose with physiological solution at a rate of 20–40 drops/min.
Diagnosis of uteroplacental insufficiency (stress test with oxytocin)
Start the infusion at a rate of 0.5 mIU/min and double the rate every 20 minutes until the effective dose is reached, which is usually 5–6 mIU/min, up to 20 mIU/min. After the appearance of 3 moderate uterine contractions lasting 40–60 s each over a 10-minute period, you should stop administering oxytocin and monitor the change, that is, the slowdown in fetal cardiac activity.

Side effects:

From the outside endocrine system : vasopressin-like effect.
From the outside digestive system : nausea, vomiting.
From the cardiovascular system: heart rhythm disturbance.
From the outside reproductive system : uterine hypertonicity, discoordinated or excessively strong labor, uterine rupture, intrauterine fetal suffering (bradycardia, arrhythmia, asphyxia), premature placental abruption.
Allergic reactions: skin rashes, itching.

Contraindications:

Oxytocin injection is contraindicated in any of the following conditions:
- clinically narrow pelvis;
- unfavorable fetal position prevents spontaneous delivery without prior intervention (transverse fetal position);
- so-called obstetric emergencies in which the benefit/risk ratio for the fetus or woman in labor requires surgical intervention;
- in cases of fetal distress long before the terminal stages of pregnancy;
- long-term use for uterine inertia or sepsis;
- uterine hypertonicity;
- hypersensitivity to active substance or any of excipients;
- induction or increase in contractile activity of the uterus in cases where vaginal birth is contraindicated (for example, with umbilical cord presentation or prolapse, complete placenta previa or vasa previa);
- severe cardiovascular disorders.

Interaction with
other medicinal
by other means:

Severe hypertension has been reported, when oxytocin was prescribed 3–4 hours after prophylactic administration of vasoconstrictors together with caudal anesthesia.
Anesthesia with cyclopropane, enflurane, halothane, isoflurane may alter the effects of oxytocin on the cardiovascular system, leading to unexpected results such as hypotension. It is also known that the simultaneous use of oxytocin and cyclopropane anesthesia can cause sinus bradycardia and atrioventricular rhythm.
Oxytocin should be administered with caution to patients taking drugs that may prolong the QTc interval.
It turned out that prostaglandins enhance the effect of oxytocin, therefore their use is not recommended. Due to increased contractility of the uterus, caution should be exercised with the sequential use of prostaglandins and oxytocin.
Concomitant use of oxytocin with other inducers of labor or abortion can lead to uterine hypertension (increased tone), uterine rupture or cervical injury (for example, the use of prostaglandins can increase the stimulation of labor and myometrial stimulation).
Therefore, when using the drug in patients, it is necessary to strictly monitor: acid-base balance; frequency, duration and strength of uterine contractions; fetal heartbeat; maternal heart rate and blood pressure; uterine tone; fluid balance.

Incompatibility. The drug can be diluted in 0.9% sodium chloride solution for infusion, 5% glucose solution, sodium lactate solution. Ready solution physically and chemically stable for 8 hours after preparation. From a microbiological point of view, the drug should be used immediately. Should not be administered in the same volume with other drugs.

Pregnancy:

There are no known indications for use in the first trimester of pregnancy, other than in connection with spontaneous or induced termination of pregnancy. Wide experience with the use of the drug, its chemical structure and pharmacological properties indicate that when using this medicine according to indications, it does not lead to the formation of fetal malformations.
In small quantities penetrates into breast milk.
In cases where the drug is used to stop uterine bleeding, breastfeeding is possible only after completing the course of treatment with oxytocin.
Children. Not used in children.

Overdose:

Symptoms depend mainly on the degree of hyperactivity of the uterus, regardless of the presence of hypersensitivity to the drug. Hyperstimulation can lead to intense (hypertonic) and prolonged (tetanic) contractions of the uterus or rapid labor with a characteristic basal myometrial tone of 15–20 or more mm aqueous. Art., measured between two contractions, and can also cause rupture of the body or cervix, vagina, bleeding in the postpartum period, uteroplacental hypoperfusion, slow fetal cardiac activity, hypoxia, hypercapnia and fetal death.

Solution for injection and local use - 1 ml contains:
Active ingredient - Oxytocin 5 IU
Other Ingredients: acetic acid, chlorobutanol, ethyl alcohol.

Instructions for the use of Oxytocin for prevention and treatment
gynecological diseases in female farm and domestic animals
(developer organization: Mosagrogen CJSC, Moscow)

I. General information
Trade name medicinal product: Oxytocin.
International generic name: oxytocin.

Dosage form: solution for injection.
The drug in 1 ml contains oxytocin 5 or 10 IU as an active ingredient, nipagin - 0.5 mg as auxiliary components, as well as water for injection.
By appearance the drug is a clear, colorless solution.

The drug is produced packaged in 10, 20 and 100 ml in glass bottles of appropriate capacity, sealed with rubber stoppers reinforced with aluminum caps.

Store the medicinal product in the manufacturer's sealed packaging in a dry place, protected from direct sunlight, separately from food and feed, at a temperature of 1°C to 25°C.
The shelf life of the medicinal product, subject to storage conditions, is 2 years from the date of production. After opening the bottle
Unused remains of the drug cannot be stored. It is prohibited to use the drug after its expiration date. Should be kept out of the reach of children.
Unused medicinal product is disposed of in accordance with legal requirements.

II. Pharmacological properties
Pharmacological group - hormones and their antagonists.
Oxytocin is a synthetic polypeptide analogue of the hormone of the posterior lobe of the pituitary gland. It has a stimulating effect on the smooth muscles of the uterus, especially at the end of pregnancy, as well as during labor.
Oxytocin stimulates milk secretion by increasing the production of prolactin by the anterior pituitary gland. Contracts the myoepithelial cells around the alveoli of the mammary glands, stimulates the flow of milk into large ducts or sinuses, promoting increased milk secretion. It is practically devoid of vasoconstrictor and antidiuretic effects (only in high doses), does not cause contraction of the muscles of the bladder and intestines. The effect occurs within 1-2 minutes with subcutaneous and intramuscular administration, lasts 20-30 minutes; with intravenous injection - after 0.5-1 minutes.

In accordance with the classification GOST 12.1.007-76, the drug belongs to substances of hazard class 4 - low-hazard substances.

III. Application procedure
Oxytocin is used in female farm and domestic animals: for weak labor, retained placenta, reflex agalactia, mastitis and uterine bleeding.

The drug is contraindicated during obstetrics in cases of a large fetus, its deformity, and also in case of incorrect position.

Oxytocin is administered to animals subcutaneously, intramuscularly, intravenously, and, if necessary, in combination with novocaine epidurally in the doses indicated in the table:

*ME - international units.

No overdose symptoms have been identified in animals.
The specific effects of the drug upon its first use and upon its withdrawal have not been established.
If the interval between two administrations of the drug accidentally increases, it should be administered as soon as possible in the prescribed dosage.
When using the drug in accordance with these instructions, side effects and complications in farm animals, as a rule, are not observed.
The use of the drug does not exclude the use of other medications.
During the period of oxytocin use, there are no restrictions on the use of animal products for human food.

IV. Personal prevention measures
When working with Oxytocin, you should follow the general rules of personal hygiene and safety precautions provided for when working with medications. After finishing work, wash your hands with warm water and soap.
In case of accidental contact of the drug with the skin or mucous membranes of the eye, they must be rinsed with plenty of water. People with hypersensitivity to the components of the drug should avoid direct contact with Oxytocin. If allergic reactions or if the drug accidentally enters the human body, you should immediately contact medical institution(bring with you the instructions for use of the drug or the label).

Empty drug bottles must not be used for household purposes; they must be disposed of with household waste.

Manufacturer: JSC "Mosagrogen"; 117545, Moscow, 1st Dorozhny proezd, 1.